Etude publiée dans pubmed le 14 juin 2021. Pas facile pour le néophyte (même comprenant l'anglais) de savoir le sens des conclusions. Les données utilisées sont pour les plus récentes de 2018 (224.775 patients), les plus anciennes de 2012 (voir les courbes d'évolution à la fin de l'extrait). La durée moyenne de traitement était de 2 à 3 ans, l'âge moyen de patients entre 76 et 78 ans (plus ou moins 12 ans),
- 1EPI-PHARE (French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM)), Saint-Denis, France.
- 2Ophthalmologic Center, Châtellerault, France.
- 3University Paris-Saclay, UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Abstract
Purpose: To describe the sociodemographic, medical and management characteristics of patients using intravitreal (IVT) anti-vascular endothelial growth factors (VEGF) in France.
Methods: An observational study was conducted in patients treated with IVT ranibizumab or aflibercept, aged 18 years or older using the French National Health Insurance Databases covering 99% of the French population. Patients currently treated in 2018 were included in a cross-sectional approach to describe treatment history over the previous 6 years. Patients newly treated between 2014 and 2018 were included in a longitudinal approach to describe treatment management during up to 6 years of follow-up. Sociodemographic characteristics and medical history were described in both populations. The analyses were performed at the patient level, as no distinction between the eyes could be made.
Results: A total of 224 775 current users of IVT anti-VEGF in 2018 (mean age 78.1 ± 11.3 years, 60% female) and 330 969 new users between 2014 and 2018 (mean age 75.9 ± 12.0 years, 59% female) were included. In both populations cardiovascular comorbidities or risk factors were frequent and the main treatment indications were age-related macular degeneration and diabetic macular oedema. Among current users of IVT anti-VEGF in 2018, the mean number of years receiving a treatment was 2.9 ± 2.0 years, with a mean of 13.7 ± 11.8 dispensations. In the longitudinal approach, a 26% increase in IVT anti-VEGF initiation was observed between 2014 and 2018. For new users, the mean number of years receiving a treatment was 1.6 ± 1.6 and 67% had at least three dispensations within the first three months. A treatment interruption was observed for 83% of new users and occurred on average of 6.1 ± 8.1 months after initiation. The mean number of dispensations was 4.8 ± 2.8 in the first year and 2.2 ± 2.9 in the second year. The mean number of eye monitoring examinations was 6.5 ± 4.7 in the first year and 4.6 ± 4.4 in the second year.
Conclusion: This study described the real-world conditions of IVT anti-VEGF dispensing at the entire French population scale. Less frequent dispensations and surveillance examinations were observed than in monthly schemes applied in registration trials for IVT anti-VEGF. These results may indicate a lack of systematic monitoring associated with fewer injections and/or clinicians' preference for more flexible and personalized injection schemes than those originally recommended.
Keywords: aflibercept; age-related macular degeneration; choroidal neovascularization; intravitreal anti-vascular endothelial (anti-VEGF) growth factor; longitudinal study; macular angiogenesis; pharmacoepidemiology; ranibizumab; real-world study.
© 2021 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.
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